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Trial registered on ANZCTR


Registration number
ACTRN12618001911280
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
23/11/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Balloon Contouring.
Scientific title
An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate the Safety of Focal Balloon Contouring.
Secondary ID [1] 296643 0
Nil Known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 310479 0
Condition category
Condition code
Skin 309191 309191 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Focal Balloon Contouring system consists of a set of tools to evaluate a new procedure called Focal Balloon Contouring to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks. This procedure, lasting approximately 60 - 90 minutes, will be done by a plastic surgeon or surgical dermatologist in their clinic. After local anaesthetic has been applied to the intended area, this experimental procedure/intervention involves a small opening (less than 1cm) made in the skin at the intended procedural area of mid-thigh/buttock, and inserting a small balloon just under the skin which is then inflated to stretch and release this connective tissue support system of the fat, or fibrous septa. By doing this to areas of cellulite it is hoped that a visual change may occur which could potentially improve the overall impression of cellulite areas. This improvement could be seen as “contouring” an area and occurs at one visit with one side being treated. The side to be treated is at the discretion of the treating doctor.
Intervention code [1] 312956 0
Treatment: Devices
Comparator / control treatment
Prospective study designed as a single-arm, paired comparison study wherein participants serve as their own control. Bilateral photography is performed at all visits, including baseline, however only one side (unilateral) treatment will occur allowing for same-patient comparison.
Control group
Active

Outcomes
Primary outcome [1] 308167 0
Safety of the Focal Balloon Contouring System determined by the absence of serious adverse device effects during the study. The data will be collected as reported by the patient and medical records.
Timepoint [1] 308167 0
Data will be collected at all patient visits including Procedure through to Day 90 (3 month) post procedure follow up visit.
Secondary outcome [1] 354126 0
Feasibility (percentage of participants the procedure produces an effect).
Timepoint [1] 354126 0
Determined by the percentage of participants having a reduction in the appearance of their cellulite in the procedure area according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician assessment of participant photographs taken pre-operatively, 30 days and 90 days after procedure, with the secondary endpoint considered reached if greater than 50% of participants have an improvement by the GAIS at 90 days.

Eligibility
Key inclusion criteria
* Moderate or severe cellulite in the thighs and/or buttocks
* BMI less than 30
* Caucasian
* Fluency in both written and spoken English
* Negative urine pregnancy test
* Will not try any other cellulite procedures through the follow-up period
Minimum age
21 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Cellulite procedure on the thighs or buttocks in the last 12 months
* Prior liposuction in the thighs or buttocks
* Greater than 10% increase or decrease in body weight within the last six months or history of greater than 60 kilograms weight loss
* Evidence of an active infection or fever greater than 38oC
* Current or recent smoker (within 6 months)
* History of hypertension, diabetes or hypoglycaemia
* Non-Caucasian
* Pregnant or breast feeding
* History of coagulopathy(ies) or pneumopathy
* History of severe anaemia
* Has atrophic scars, or a history of atrophic scars or keloids
* Taken within 14 days of procedure:
a. NSAIDs (e.g., aspirin, ibuprofen, naproxen)
b. Vitamin E, herbal teas or dietary supplements (e.g., Gingko Biloba, Willow Bark)
* Any known factor, condition or disease that in the opinion of the physician might interfere with procedure compliance, study conduct or interpretation of the results such as skin laxity, co-existent psychiatric disease, history of noncompliance to medical regimens, or unwillingness to comply with study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not Applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single-arm, paired comparison study wherein participants serve as their own control..
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be performed on all participants who met all inclusion and none of the exclusion criteria. The study is not powered to make statistically valid comparisons with historical data. All comparisons will be qualitative in nature..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2018
Actual
16/11/2018
Date of last participant enrolment
Anticipated
9/12/2018
Actual
3/12/2018
Date of last data collection
Anticipated
31/01/2019
Actual
16/04/2019
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 24732 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 301222 0
Commercial sector/Industry
Name [1] 301222 0
NC8 Australia Pty Ltd
Country [1] 301222 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NC8 Australia Pty Ltd
Address
58 Gipps Street, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 300856 0
None
Name [1] 300856 0
Not Applicable
Address [1] 300856 0
Not Applicable
Country [1] 300856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301966 0
Bellberry HREC
Ethics committee address [1] 301966 0
Ethics committee country [1] 301966 0
Australia
Date submitted for ethics approval [1] 301966 0
17/09/2018
Approval date [1] 301966 0
14/11/2018
Ethics approval number [1] 301966 0
2018-08-620

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88698 0
Dr Craig Layt
Address 88698 0
The Layt Clinic
16 Harvest Court
Southport QLD 4215
Country 88698 0
Australia
Phone 88698 0
+61 7 5597 4100
Fax 88698 0
+61 7 5587 6100
Email 88698 0
craig@thelaytclinic.com
Contact person for public queries
Name 88699 0
Craig Layt
Address 88699 0
The Layt Clinic
16 Harvest Court
Southport QLD 4215
Country 88699 0
Australia
Phone 88699 0
+61 7 5597 4100
Fax 88699 0
+61 7 5587 6100
Email 88699 0
craig@thelaytclinic.com
Contact person for scientific queries
Name 88700 0
Earl Bright
Address 88700 0
NC8 Australia Pty Ltd
58 Gipps Street,
Collingwood VIC 3066
Country 88700 0
Australia
Phone 88700 0
+61 3 9419 7607
Fax 88700 0
Not Applicable
Email 88700 0
ebright@exploramed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.